tbuckley/cabot-search huggingface dataset:
Racial and ethnic disparities in employment of patients and caregivers following breast cancer diagnosis.
Authors: Marisa C. Weiss, Sam Meske, Muath Giaddui, Jennifer Uscher, Donna-Marie Manasseh, Sherry Danese, Julie Ulloa, Bridgette Thom, Fumiko Chino
Journal: Journal of Clinical Oncology (2023)

6543 Background: Breast cancer (BC) can negatively impact employment, risking healthcare benefits, financial security and quality of life, especially for underserved minority populations. To better understand the impact of BC diagnosis and treatment on employment, Breastcancer.org conducted an online survey. Methods: Between 6/7-7/12/2022, Breastcancer.org community members were recruited to participate in an anonymous survey in English or Spanish via email, social media, or website ads. Eligible participants were US residents, age ≥18, and diagnosed with BC within the past 10 years. Consented participants answered questions on socio-demographics, financial toxicity, and employment status. Results: Of 2,420 screened, 1,710 met eligibility, and 1,437 participated (84% participation rate). Mean age and time since diagnosis was 46 and 2 years, respectively; 75% were in active treatment for non-metastatic (89%) or metastatic (11%) BC. Patients identified as 60% White (n=868), 26.7% Hispanic (n=384), 8% Black (n=121), or 4% Other (n=64). 94% were women. BC negatively impacted employment for 92% of patients. Full-time employment went from 62% at diagnosis to 40% by the time of the survey. This was more pronounced in metastatic (56% to 25%) vs non-metastatic (63% to 42%) patients (p=0.015). 64% attributed employment changes to their diagnosis, noting reduced hours/income (40%), job change (26%), disability (13%), permanent job loss (13%), and/or early retirement (12%). 36% noted changes in their caregiver’s employment status as well with 30% of caregivers having reduced hours/income, 30% taking time off work, and 27% changing jobs; 9% of caregivers had permanent job loss and 10% retired early. Hispanic patients were younger (p&lt;0.001) and more likely to have young children (p&lt;0.001) and take unpaid leave (p=0.02). (Table). BC diagnosis was also more likely to impact their caregiver’s employment (58%, vs White 25% or Black 41% patients, p&lt;0.001). Conclusions: Breast cancer can cause significant, lasting negative effects on employment status for patients and caregivers that can decrease financial security of the entire family unit. Hispanic patients and individuals with metastatic disease appear to be at highest risk. Legislative protections and financial support may be required to mitigate the significant financial toxicity of a cancer diagnosis, especially for the most vulnerable. [Table: see text]
Head-to-head effectiveness and safety of pembrolizumab plus axitinib vs. nivolumab plus ipilimumab in metastatic renal cell carcinoma in the United States.
Authors: Dvir Aran, Einat Granot-Hershkovitz, Shlomit Amar-Farkash, Keren Rosenberg-Katz
Journal: Journal of Clinical Oncology (2023)

4532 Background: Two main first-line combination therapies for metastatic renal cell carcinoma (mRCC) are pembrolizumab plus axitinib (P+A) and nivolumab plus ipilimumab (N+I). No head-to-head clinical trial comparing these treatments has been performed, and the available real-world data (RWD) on their effectiveness is limited. Here, we used RWD to compare the overall survival and posttreatment hospitalization rates of mRCC patients receiving P+A vs. N+I. Methods: We included mRCC patients treated with N+I or P+A between 6/2018 and 3/2022, utilizing data from Elevance Health administrative claims and clinical data from AIM Cancer Care Quality Program. Inverse probability of treatment weighting (IPTW) was used to adjust for age, sex, socioeconomic deprivation index (SDI), ECOG performance status (PS), Charlson Comorbidity Index (CCI), and metastatic sites. Real-world overall survival (rwOS) was defined from first treatment until death or last claim and was estimated using weighted Kaplan-Meier method. Favorable risk was defined based on PS (&lt;2) and with a treatment initiated less than 1 year from diagnosis. Results: We identified 764 mRCC patients, of them 483 were treated with N+I (63%). The P+A group was slightly older (p=0.08), while other features were similar in both groups. Survival analysis using IPTW showed a borderline significant advantage of P+A vs. N+I (p-value=0.07). Inspection of the Kaplan-Meier curves suggested that P+A provides short-term survival benefit: 12-month rwOS was 86% for P+A vs. 77.8% for N+I (p&lt;0.001), while at 24-months, where power was lower, the curves almost converged (rwOS: 68% in P+A vs. 65% in N+I; p=0.52). In a subset of patients with favorable risk (N=69 P+A, N=68 N+I), the P+A survival improvement extended to at least 24-months (p=0.06). Finally, the N+I group had significantly higher rates of posttreatment hospitalizations (3-months after treatment initiation) compared to the P+A group (31.9% vs. 19.6%; p-value&lt;0.001). Conclusions: Our retrospective cohort study suggests that P+A may provide short-term survival benefits over N+I, and this benefit is extended in patients with favorable risk. P+A is also associated with fewer post-treatment hospitalizations. We argue that the higher toxicity of N+I may explain its lower short-term effectiveness and may also explain its lower effectiveness in patients with favorable risk. [Table: see text]
Preventable emergency department visits and admissions for patients on chemotherapy including oral chemotherapy.
Authors: Kian Tehranchi, Ashley L. O’Donoghue, Tenzin Dechen, Emmeline Academia, Jennifer P. Stevens, Jessica Ann Zerillo
Journal: Journal of Clinical Oncology (2023)

e18736 Background: OP-35 is a CMS quality metric used to quantify ED visits and admissions for 10 preventable conditions in the 30 days after chemotherapy. While CMS limited this metric to IV chemotherapy, oral chemotherapy (OC) also poses risk of significant adverse effects. This study aimed to compare the rates of ED visits and admissions between patients on IV chemotherapy, OC, or both. Methods: This single center retrospective analysis included patients with cancer receiving outpatient chemotherapy and those who visited the ED within 30 days of receiving chemotherapy between 1/2019-12/2022. OC broadly included cytotoxic, targeted, and hormonal therapies. The primary outcome was the proportion of ED visits and admissions for preventable diagnoses, as defined by OP-35, between patients receiving IV chemotherapy, OC, or both. T-tests were used to compare continuous variables with a p-value &lt; 0.05 considered statistically significant. Results: Of the patients receiving OC, 15% were on a cytotoxic therapy, 26% were on a targeted therapy, 53% were on a hormonal therapy, and 6% were on multiple agents. Among all patients on chemotherapy, 24% visited the ED within 30 days of treatment. 53% of patients on IV chemotherapy visited the ED, compared to 9% of patients on OC and 9% of patients on both IV and oral treatment (p &lt; 0.001). 45% of patients on IV chemotherapy were admitted, compared to 7% of patients on OC and 7% of patients on both IV and oral treatment (p &lt; 0.001). However, there was no significant difference in rates of ED visits (p = 0.19) or admissions (p = 0.12) for preventable (OP-35) diagnoses between patients on IV chemotherapy, OC, or both, with close to a third of ED visits and admissions being preventable in each group (Table 1). Conclusions: Despite concerns over the vulnerability of patients on OC, in this single center study patients on OC were less likely than patients on IV chemotherapy to visit the ED or require admission, with similar rates of preventable visits. Future analyses will stratify results by class of OC to assess for any differences. While OC may not produce similar rates of acute care visits as IV chemotherapy, approximately one-third could be preventable and may be improved by similar interventions as those targeting patients on IV chemotherapy. [Table: see text]
A proteomic signature associated with prognosis in HPV-related locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC).
Authors: Jia (Jenny) Liu, Christopher Jackson, Asim Anees, Zainab Noor, Steven Williams, Sandro Porceddu, Howard Liu, Rahul Ladwa, Joseph Whitfield, Roger R Reddel, Qing Zhong, Benedict J Panizza, Phillip J Robinson
Journal: Journal of Clinical Oncology (2023)

6055 Background: Although HPV-related LA-OPSCC is associated with better prognosis than HPV-negative disease, ~30% of cases relapse despite curative-intent chemoradiotherapy. New prognostic biomarkers are needed to rationalise curative-intent treatment without compromising efficacy. We aimed to develop a proteomic signature associated with risk of recurrence from diagnostic biopsies of patients with HPV-positive OPSCC. Methods: We analysed 139 formalin fixed paraffin embedded archival core biopsy specimens from 124 patients with HPV-related (p16 IHC positive) T1-4N0-3M0 LA-OPSCC tumours. All patients were treated with definitive chemoradiotherapy at the Princess Alexandra Hospital (Brisbane, Australia) between 2007-2019. The cohort included 50 patients with recurrence less than five years from diagnosis and 74 age/performance-status matched patients with no recurrence. Proteomic analysis was performed utilizing data-independent acquisition mass spectrometry (DIA-MS). A proteomic prognostic signature associated with recurrence free survival (RFS) at five years was the primary endpoint of interest. It was developed using a computational pipeline comprising an initial univariate Cox model step, followed by multiple runs of multivariate Cox models with Least Absolute Shrinkage and Selection Operator (LASSO) regularization, and then a final step of recursive feature selection. Results: A total of 7,597 proteins were quantified and 665 were differentially expressed proteins between tumour and normal adjacent tissues. There were 5,199 proteins remaining in the tumour samples after filtering. RFS was significantly (q-value &lt; 0.05) associated with 252 proteins, whose functions are enriched in adaptive and innate immunity and MAPK6/MAPK4 signalling pathways. A 16-protein signature associated with RFS stratified patients into low, intermediate, or high-risk groups (C-index = 0.885, p &lt; 0.0001). The 16-protein signature outperformed clinico-pathological covariates including age, stage, ECOG and smoking history with the highest area under the receiver operating characteristic curve (AUROC 0.95). Conclusions: DIA-MS-based proteomics on core biopsies can be used to risk stratify HPV-related OPSCC patients. A 16-protein signature associated with RFS was successfully identified as a basis for future studies. Validation of this proteomic prognostic signature in independent cohorts is required and may be used to inform future clinical trials to better tailor upfront therapy.
Efficacy and safety of first-line treatments for patients with advanced hepatocellular carcinoma: A systematic review and network meta-analysis.
Authors: Danni Li, Jingyi Li, Yunpeng Liu, Xiujuan Qu
Journal: Journal of Clinical Oncology (2023)

4094 Background: In recent years, the first-line treatment options for advanced HCC has been increasingly abundant, including transarterial therapies, combination of the immune checkpoint inhibitors (ICIs) and the anti-vascular endothelial growth factor (VEGF) inhibitor, ICIs combined with ICIs, and tyrosine kinase inhibitors. However, it remains to be confusing which treatment pattern would benefit people most, especially for different subgroups. Methods: A systematic literature search was conducted on PubMed, Embase, Cochrane Central Register of Controlled Trials, and American Society of Clinical Oncology and European Society of Medical Oncology meeting proceedings for III phase randomized clinical trials (RCTs) investigating first-line treatments for HCC compared with sorafenib. The survival outcomes and toxic effects of RCTs should be reported, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs) of grade 3 or higher. This systematic review was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Guidelines. The random-effects model was used to calculate the summary hazard ratios (HRs) of OS and PFS. The likelihood of ORR, and AEs of grade 3 or higher was performed by odds ratios (ORs) using a random-effects model. Results: A total of 13 phase III RCTs involving 8505 patients were included in this study. Hepatic arterial infusion of oxaliplatin combined with fluorouracil (FOHAIC-1) showed OS, PFS, and ORR benefit over all other first-line therapies, except for the regimen of sorafenib plus HAIC of FOLFOX (OS: HR, 0.88; 95% CI, 0.37-2.09; ORR: OR, 1.53; 95% CI, 0.29-8.13). More importantly, we found that sorafenib combined with FOLFOX was superior to other regimens in patients with HBV infection regarding OS except FOHAIC-1 (HR, 0.57; 95%CI, 0.21-1.52) and tremelimumab-durvalumab (HR, 0.42; 95%CI, 0.16-1.11). While in HCV-infected subgroup, ICIs combined with anti-VEGF inhibitor improved OS benefit compared with tremelimumab-durvalumab (HR, 0.31; 95% CI, 0.11-0.84) and sorafenib (HR, 0.38; 95% CI, 0.16-0.88). HAIC-FO also showed significant OS benefits to other therapies in patients with portal invasion or extrahepatic metastasis. The probability of adverse events of grade 3 or higher was significantly lower with HAIC-FO than with others except for nivolumab (RR, 0.96; 95%CI, 0.51-1.82) and tislelizumab (RR, 0.57; 95%CI, 0.30-1.08). Conclusions: This network meta-analysis supports arterial infusion as the first-line treatment for patients with HCC. In portal invasion and extrahepatic metastasis subgroups, HAIC-FO may be a preferred option, with sorafenib combined with FOLFOX as an additional option in those with HBV infection. Besides, novel combination therapy should be focused on in patients with certain subgroups.
Anti–PD-1 combination regimen as first-line therapy in advanced biliary tract cancer and biomarker exploration: A retrospective study.
Authors: Jingyi Guo, Qun Zhou, Mingzhen Zhou, Hengheng Dai, Lin Li, Baorui Liu, Jie Shen
Journal: Journal of Clinical Oncology (2023)

e16130 Background: Combination strategy of immune checkpoint inhibitors has potential to replace chemotherapy as a new first-line therapy for advanced biliary tract cancer (BTC). The aims of this study were to assess the efficacy of anti-PD-1 combination therapy in the first-line treatment of advanced BTC and to find reliable biomarkers associated with overall survival (OS). Methods: Clinical data from patients with advanced BTC who received chemotherapy or anti-PD-1 combination therapy as first-line were collected. The primary outcome of this study was OS. Blood test results were collected from patients who received anti-PD-1 in the week prior to treatment to calculate inflammation scores and analyze their relationship with OS. A total of eight scores were selected for analysis, including platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-C-reactive protein (CRP) ratio (LCR), lymphocyte-to-monocyte ratio (LMR), CRP to-albumin ratio (CAR), systemic immune-inflammation index (SII), prognostic nutritional index (PNI), and pan-immune-inflammation value (PIV). Moreover, archival tissues were collected for genetic testing and immunohistochemical staining to analyze genetic changes and the infiltration of immune cells in tumor tissues in relation to survival. Results: From January, 2018, to July, 2022, 64 patients were recruited: 11 were in the chemotherapy group, 21 were in the anti-PD-1 plus chemotherapy group, 21 were in the anti-PD-1 plus targeted therapy group and 11 were in the triple group (anti-PD-1 plus chemotherapy and targeted therapy). The median overall survival (mOS) was 7.9 months, 11.3 months, 12.8 months and 28.7 months, respectively. Compared to first-line chemotherapy, mOS was significantly prolonged in the triple group ( p= 0.031). The results of inflammation scores showed that patients with high LCR (≥0.4), high LMR (≥2.5), low CAR ( &lt; 0.18), high PNI (≥44.3) or low PIV ( &lt; 480.9) had significantly prolonged mOS compared to those with different scores ( p&lt; 0.05). Genetic testing results suggested that patients with poor survival all had TP53 mutations and had higher levels of KRAS and ERBB2 mutations. Immunohistochemical results showed that a low FOXP3/CD8 ratio (≤0.27) was associated with prolonged OS ( p= 0.029). With CD4-low, CD8-high, CD56-positive, CD163-high, FOXP3-high and MPO-high in TME as one factor, we calculated immunoscore according to the number of factors. The high immunoscore group ( &gt; 2) showed significantly superior OS ( p= 0.003). Conclusions: First-line anti-PD-1 antibody combination therapy was superior to chemotherapy, and triple therapy significantly improved survival. Peripheral blood immune-inflammation score, FOXP3/CD8 ratio and immunoscore have potential as biomarkers for predicting the efficacy of first-line anti-PD-1 antibody therapy in advanced BTC.
Association between serum folate and vitamin B12 and cervical high-risk human papillomavirus (HPV) infection.
Authors: Josephine Peitz, Clement Adebayo Adebamowo, Sally Nneoma Adebamowo
Journal: Journal of Clinical Oncology (2023)

5541 Background: Serum concentration of folate (vitamin B9) and vitamin B12 were inversely associated with cervical intraepithelial neoplasia and cervical cancer in some studies. The association between folate and vitamin B12, and human papillomavirus (HPV) infection has not been well elucidated. We evaluated whether low serum level of folate and vitamin B12 was associated with high-risk HPV (hrHPV) infection. Methods: The study population was 6,452 women, aged 18-59 years old, enrolled in the National Health and Nutrition Examination Survey (NHANES), from 2003 to 2016, in the United States. In this cross-sectional study, odds ratios (ORs) of hrHPV were calculated, by quintiles of low folate and vitamin B12 combined, using logistic regression models. Results: The mean age (standard deviation) of the women was 36.98 (12.19) years. Women in the lowest quintile had less than 20.6 nmol/L of folate and less than 248 pmol/L of vitamin B12. Some of the women, 23% (1,509/6,452), were hrHPV positive. In age-adjusted models, low folate and vitamin B12 was significantly associated with hrHPV infection. The ORs and 95% confidence intervals (CI) was (OR: 0.704, 95% CI: 0.509 - 0.975, p = 0.034) for the second, (OR: 0.671, 95% CI: 0.479 - 0.940, p = 0.020) third, (OR: 0.534, 95% CI: 0.370 - 0.770, p = 0.0008) fourth and (OR: 0.476, 95% CI: 0.33 - 0.679, p &lt; 0.0001) fifth quintiles, compared to women in the lowest quintile. The association remained statistically significant after the models were further adjusted for smoking status and income level; women in the highest quintile were less likely to have hrHPV infection compared to those in the lowest quintile (OR: 0.541, 95% CI: 0.343 - 0.855, p = 0.008). Conclusions: This study supports an association between low serum levels of folate and vitamin B12, and hrHPV infection, among women in the United States.
Trends in utilization of first-line palliative care in non-metastatic hepatocellular carcinoma.
Authors: Muhammet Ozer, Suleyman Yasin Goksu, Ilyas Sahin
Journal: Journal of Clinical Oncology (2023)

e16234 Background: Palliative care therapies are known to improve the quality of life and even the survival of some patients. Although non-metastatic (stages I-III) hepatocellular carcinoma (HCC) patients often present with significant symptoms, first-line palliative care treatment is uncommon in this setting. Here we characterized rates of palliative care utilization among non-metastatic HCC patients and determined factors associated with palliative care receipt. Methods: We conducted a retrospective review of adult National Cancer Database patients diagnosed with metastatic HCC between 2004 and 2019. We used descriptive analysis for determining palliative care utilization, including palliative chemotherapy, surgery, radiotherapy, and pain management. We performed multivariable logistic regression analysis to assess the association of characteristics with palliative treatment utilization. Results: Among 121,151 patients diagnosed with stage I-III HCC, the utilization of first-line palliative care subsets was only a small portion of 3966 (3.3%). The most commonly used palliative care treatment was pain management (37.4%), followed by systemic chemotherapy (31.1%), radiotherapy (13%), surgery (9.9%), and combination therapies (8.6%). The higher stage, high comorbidity score, and decreased life expectancy were more likely to be associated with received PC. Stage 2 and 3 diseases were associated with increased odds of PC receipt compared to stage 1 disease (odds ratio [OR] = 1.63 [1.45-1.83] and OR = 3.57 [3.22-3.95]; respectively). Comorbidity score 3 was significantly more likely to receive PC than comorbidity score 0 (OR = 1.54 [1.41–1.69]). In addition, life expectancy &gt;24 months was significantly less associated with PC receipt compared to life expectancy &lt; 6 months (OR: 0.23 [0.20-0.26]). Conclusions: First-line palliative care subsets are underutilized to control symptoms among patients with non-metastatic HCC. Targeted efforts should be focused on increasing palliative care delivery in this group which has a vast potential to benefit.